This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.

开始日期2025-10-01

申办/合作机构

Duke University

NCT07019545

/ Not yet recruiting临床2期IIT

A PHASE II TRIAL AIMING TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN IN ADULT PATIENTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA PREVIOUSLY TREATED WITH A THROMBOPOIETIN RECEPTOR AGONIST AND/OR RITUXIMAB AFTER CORTICOSTEROID FIRST-LINE THERAPY

This is a Phase II open label, prospective, multicenter trial designed to assess the safety and clinical activity of belantamab mafodotin in adult patients with primary immune thrombocytopenia (ITP) previously treated with a thrombopoietin receptor agonist (TPO-RA) and/or rituximab after first-line treatment with corticosteroids. Overall, 14 participants will be enrolled in the trial. Participants' follow-up will continue for up to 12 months after the last participant is enrolled. The accrual period will be approximately 12 months.
Trial treatment will be given in 28-day cycles for a total period of one year per patient or until treatment failure, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Participants without confirmed Response (R) or better after two infusions with belantamab mafodotin will be discontinued from trial treatment and will not be replaced.

开始日期2025-06-20

申办/合作机构

Hellenic Society of Cardiology

NCT06232044

/ Suspended临床1/2期IIT

A Phase I/II Study of the Safety, Tolerability and Efficacy of Belantamab Mafodotin (GSK2857916) in Combination With Iberdomide (CC-220)/Dexamethasone Versus Belantamab Mafodotin (GSK2857916)/Dexamethasone in Relapsed Refractory Multiple Myeloma

This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.

开始日期2025-04-23

申办/合作机构

Alliance for Clinical Trials in Oncology

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项与玛贝妥单抗相关的文献（医药）

2025-10-01·Clinical Lymphoma Myeloma & Leukemia

Practical Guidance on the Clinical Management of Belantamab Mafodotin for Patients With Relapsed/Refractory Multiple Myeloma: Recommendations From the Middle East and North Africa Expert Panel

Article

作者: Mutahar, Enas Yahya ; Beksaç, Meral ; Palamar, Melis ; Dal, Mehmet Sinan ; Saydam, Guray ; Sahli, Esra ; Alhuraiji, Ahmad ; Marashi, Mahmoud ; Tombak, Anil ; Hosny, Mohamed ; Alhejazi, Ayman ; Mattar, Mervat ; Rabea, Ahmed

Multiple myeloma (MM) remains a substantial cause of mortality in the Middle East and North Africa, with incidence rising in the region. MM is challenging to treat because many people relapse and/or become refractory to standard of care. Additional challenges in the Middle East and North Africa region include reduced access to newer therapies, resulting in poorer outcomes than in other regions. Belantamab mafodotin-a first-in-class antibody-drug conjugate targeting B-cell maturation antigen-has shown significant efficacy in the recent DREAMM-7 and DREAMM-8 phase 3 trials for patients with relapsed/refractory MM. However, participants experienced a high incidence of ocular adverse events, due to the off-target effects of monomethyl auristatin F, a microtubule inhibitor responsible for belantamab mafodotin's antimyeloma activity. Belantamab mafodotin is currently under regulatory review in several countries; thus, healthcare providers need specific regional guidance to manage these ocular side effects. A panel of 13 experts in hematology/oncology and ophthalmology from Turkey, Egypt, Saudi Arabia, the United Arab Emirates and Kuwait developed these practical recommendations. The recommendations, formulated through detailed discussions, evidence review and clinical experience, focused on several themes around identification and management of ocular adverse events with a specific emphasis on prevention of severe ocular events.

2025-10-01·EJHaem

Real‐World Treatment Patterns and Clinical Outcomes Among Patients With Triple‐Class–Exposed and BCMA‐Exposed Multiple Myeloma Within the United States

Article

作者: Le, Hoa H. ; Zhang, Xinke ; Mian, Hira S. ; Patel, Saurabh ; Fu, Alex Z. ; Harper, Jennifer S. ; Fonseca, Rafael

ABSTRACT:

Introduction:

A novel therapy for heavily pretreated triple‐class–exposed multiple myeloma (TCE MM) is B‐cell maturation antigen (BCMA)‐targeted immunotherapy. While the number of TCE+BCMA‐exposed patients is growing, real‐world data for this group are limited.

Methods:

We present real‐world data from patients with TCE+BCMA‐exposed MM who initiated a subsequent line of therapy (LOT) using a US‐based claims database, Komodo's Healthcare Map.

Results:

We identified 656 TCE+BCMA‐exposed patients; mean age was 66.5 years. Time from MM diagnosis to index was 5.4 years; mean number of prior LOTs was 5.9. The most prevalent prior therapy received within each drug class was daratumumab (98.5%), pomalidomide (86.0%), carfilzomib (85.8%) and belantamab mafodotin (74.5%). A total of 137 different subsequent treatment regimens were observed following TCE+BCMA exposure; the most common regimen was teclistamab (10.4%). The top three targeted agents within the subsequent regimen were carfilzomib (20.2%), pomalidomide (20.1%) and bortezomib (16.6%). Among this TCE+BCMA‐exposed population who received subsequent treatment, the median time to next treatment or death was 6.8 (95% CI, 6.1–7.5) months; time to treatment discontinuation or death was 3.5 (95% CI, 3.2–3.7) months.

Conclusion:

This first real‐world analysis of patients with heavily pretreated TCE+BCMA‐exposed MM shows poor clinical outcomes, frequent therapy retreatment and no standard‐of‐care, highlighting the need for novel treatments.

Clinical Trial Registration:

The authors have confirmed clinical trial registration is not needed for this submission.

2025-10-01·Die Ophthalmologie

Review

作者: Schmidinger, Gerald ; Khoramnia, Ramin

428

项与玛贝妥单抗相关的新闻（医药）

2025-09-29

·BioSpace

6 FDA Decisions to Watch For in Q4

iStock, Grandbrothers From more than 30 target action dates in the last three months of the year, BioSpace has narrowed the list to six regulatory decisions that could have far-reaching implications for biopharma and patients. As 2025 enters its home stretch, the FDA is also nearing the end of its calendar. But that doesn’t mean that the industry is in for a quiet year-end—quite the opposite, in fact. In the last three months of 2025, the FDA is set to decide on at least 30 regulatory applications, many of which could help shift the treatment landscape for hard-to-treat diseases or push the boundaries for novel modalities. One upcoming verdict, for instance, could mark another industry first for CAR T therapies, while another could mean the comeback of a previously-pulled cancer drug. Here, BioSpace rounds up six of these most highly anticipated decisions in Q4, looking at the data backing their bids and what their approvals could mean for the industry. After Delay, Regeneron Awaits Two Eylea HD Verdicts Regeneron is looking to boost the pro high-dose Eylea with a move into macular edema after retinal vein occlusion (RVO) and a monthly dosing regimen across all its approved indications. The FDA is currently reviewing these applications and is expected to release its verdict in the fourth quarter. No specific decision date has yet been indicated. The regulator had an initial target action date of Aug. 19, but extended the review period due to issues at a third-party manufacturing site, Regeneron announced earlier that month. The production plant in contention was previously owned by the CDMO giant Catalent, which was acquired by Novo Nordisk’s parent company for $16.5 billion in February 2024 . An FDA report made public in August revealed uncontrolled and unaddressed contaminations at this site, including with bacteria and cat hair. Regeneron has nevertheless reassured investors that aside from these third-party problems, the FDA has not flagged any problems with the submission. “Based on our discussions, we believe that there’s nothing significant left to be done,” CEO Leonard Schleifer said during the company’s Q2 earnings call . “We are expecting, once the resolution of the filling issues has occurred, to receive favorable action, we hope, from the FDA.” To support its application for high-dose Eylea, Regeneron filed data from the Phase III QUASAR study, which demonstrated that the high-dose formulation was non-inferior to the currently approved standard-dose version of Eylea when used to treat patients with macular edema after RVO, according to a readout in December 2024. Adverse events were comparable between the two formulations. High-dose Eylea is currently approved for wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. GSK’s Blenrep Comeback Bid Nears Moment of Truth By Oct. 23, the FDA is expected to release its decision on GSK’s proposal to bring Blenrep back to the market, this time as a second-line treatment for relapsed/refractory multiple myeloma. Blenrep, an antibody-drug conjugate targeting the CD38 protein, was originally approved in August 2020 under the FDA’s accelerated pathway. But soon after failing its confirmatory Phase III study in November 2022, GSK withdrew the product from the market. Then, last year, GSK started setting the stage for Blenrep’s comeback with data from the Phase III DREAMM-7 trial. A readout in February 2024 demonstrated a significant 59% drop in the risk of death or disease progression in patients treated with Blenrep plus bortezomib and dexamethasone, as compared with a similar regimen using Johnson & Johnson’s Darzalex. Then, in June that same year, the pharma reported findings from another late-stage study, DREAMM-8, touting significantly better progression-free survival for Blenrep versus Takeda’s Velcade. GSK is using these two studies to support its regulatory application for Blenrep, but in July this year, the FDA’s internal reviewers flagged “high rates of ocular toxicity and dose modifications” in both trials. The DREAMM studies also had “limited dose exploration” which in turn highlight the unaddressed need for a “careful evaluation” of Blenrep’s risks in its proposed indications, according to the reviewers. An external advisory committee in July agreed with this assessment and voted 7–1 against Blenrep , finding an unfavorable benefit-risk pro the drug in its proposed indication. “The efficacy data were strong but the toxicity data were also very strong,” panelist Neil Vasan said at the time. Shortly after the vote, the FDA extended Blenrep’s review by three months. BMS’ Breyanzi Could Become First CAR T Therapy for Marginal Zone Lymphoma Bristol Myers Squibb is proposing its CAR T therapy Breyanzi for the treatment of marginal zone lymphoma (MZL), potentially blazing the trail for the therapeutic class in this indication. The FDA has a target decision date of Dec. 5. To support its application, BMS filed findings from the Phase II TRANSCEND FL study, a single-arm, open-label trial that enrolled more than 270 patients with relapsed or refractory follicular lymphoma or MZL. Data presented at the 2025 International Conference on Malignant Lymphoma in June demonstrated a 95.5% overall response rate in patients with MZL, including 62.1% who saw a complete response. The safety pro TRANSCEND FL was consistent with what had previously been established for Breyanzi. Rates of cytokine release syndrome and neurologic complications were “low,” according to BMS, with no grade 4 or 5 cases detected. If it wins the FDA’s blessing, Breyanzi would be the first CAR T therapy indicated for MZL, according to an August 2025 news release from the company. It would also mark the second time that Breyanzi notched a regulatory record: In March 2024, it became the first CAR T to win approval for chronic lymphocytic leukemia and small lymphocytic leukemia in relapsed/refractory patients. Breyanzi works by binding to the CD19 protein, in turn triggering the activation and action of CAR-T cells, as well as the release of pro-inflammatory signals to destroy the target tumor. It is also approved for large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma. The drug’s label carries a boxed warning for cytokine release syndrome, neurological toxicities and secondary hematological malignancies. Arrowhead Makes Case for RNAi Therapy in Rare Cholesterol Disease After delivering four firsts for the rare disease space in August, the FDA by Nov. 18 could grant another—this one for Arrowhead Pharmaceuticals’ plozasiran , an RNA interference therapeutic for familial chylomicronemia syndrome (FCS). Afflicting 1 to 2 people per million , FCS is an ultra-rare, heritable disease that manifests as excessively high levels of triglyceride levels, typically reaching over 880 mg/dL, according to Arrowhead . In turn, patients with FCS suffer from cardiometabolic and other complications such as diabetes, hepatic steatosis, abdominal pain and even cognitive problems. There are currently no treatments that can adequately control FCS in the U.S., according to Arrowhead. Arrowhead’s answer to FCS is plozasiran , an investigational therapy that reduces the production of the ApoC3 protein, which is naturally produced in liver cells and serves as a component of triglyceride-rich lipoproteins. ApoC3 prevents the breakdown and clearance of these fatty molecules. By reducing ApoC3 production, plozasiran helps normalize lipid levels in FCS patients. Arrowhead is supporting its application with data from the Phase III PALISADE trial. A readout in November 2024 demonstrated that 25 mg of plozasiran—the proposed commercial dose—led to a roughly 80% reduction in triglyceride levels. In at least half of the treated patients, triglyceride levels stayed below 500 mg/dl, a threshold linked with worse acute pancreatitis risk. Plozasiran treatment also resulted in lower cholesterol levels. Arrowhead is also developing plozasiran for severe hypertriglyceridemia and dyslipidemia. Ascendis Eyes Approval in Rare Bone Growth Disorder Also awaiting a rare disease decision is Ascendis Pharma, which is advancing TransCon CNP, also known as navepegritide, for the treatment of children with achondroplasia. The FDA is set to release its verdict by Nov. 30. Achondroplasia is a rare, genetic disease characterized by dwarfism due to faulty bone development. Ascendis is targeting a specific disease type caused by mutations in the FGFR3 gene, resulting in manifestations in different tissues across the body. Aside from bone problems, patients with this specific type of achondroplasia also suffer from muscular, neurological and cardiorespiratory problems. Around 250,000 people worldwide are affected by this disease, according to Ascendis. TransCon CNP works by providing sustained exposure to the C-type natriuretic peptide, a molecule that helps stimulate bone growth and counter the inhibiting effects of FGFR3 mutations. Through this mechanism, Ascendis contends that its drug candidate could help ease the burden of symptoms and complications in achondroplasia. Ascendis tested the TransCon CNP in ACcomplisH, a randomized, double-blinded and placebo-controlled Phase II study that enrolled 42 patients who received 6 μg, 20 μg or 50 μg of the drug. Results, published in The Lancet in November 2023, showed that patients on TransCon CNP saw significant improvements in annualized growth velocity, alongside other key benefits, such as a stabilized quality of life and better physical functioning. In a June 2025 statement , Ascendis Chief Medical Officer Aimee Shu said the biotech’s clinical development program for TransCon CNP is the “first ever to demonstrate improvements beyond linear growth at 52 weeks compared to placebo.” Cytokinetics Could Challenge BMS in Cardiomyopathy Market Closing out this list is Cytokinetics and its cardio candidate aficamten, which is currently under FDA review for obstructive hypertrophic cardiomyopathy (oHCM). The FDA’s target decision date is Dec. 26. Aficamten blocks the cardiac myosin protein, which plays a role in heart contraction, allowing the oral drug candidate to address a key symptom of oHCM. Data from the Phase III MAPLE-HCM study, presented in August at the 2025 European Society of Cardiology Congress, demonstrated a significant improvement in exercise capacity over metoprolol, a beta-blocker used as standard-of-care in the disease. At the time, analysts at Truist Securities said aficamten’s results position it to be “potentially best-in-class” in oHCM. They called the MAPLE-HCM data “robust,” noting that outperforming metoprolol could help aficamten distinguish itself in the oHCM market. Cytokinetics filed for aficamten’s approval in late 2024, at which time the FDA provided an initial target action date of Sept. 26, 2025 . In May, however, the regulator extended its review by three months to review an additional risk mitigation strategy submission. If approved, aficamten will compete with BMS’s Camzyos, also a cardiac myosin inhibitor that won approval for oHCM in 2022 . The pharma is testing the drug in a non-obstructive form of the heart disease, but a readout in April this year was disappointing : Camzyos was unable to significantly outperform placebo in terms of exercise capacity outcomes, nor did it lead to better physical function.

临床结果临床3期上市批准临床2期免疫疗法

2025-09-27

·药明康德

同行致远 | 双特异性ADC组合达100%客观缓解率；难治性肺癌疾病控制率近80%的创新疗法 | Bilingual

编者按：偶联药物通过将与靶蛋白结合的配体与功能性载荷连接，实现向特定组织或细胞精准递送载荷的效果。近年来，这一领域快速发展，据统计，2024年全球启动了284项抗体偶联药物（ADC）临床试验，比2023年增加了100多项，彰显了偶联药物领域的迅猛增长。ADC之外，放射性偶联药物（RDC）、多肽偶联药物（PDC）以及寡核苷酸偶联药物等新兴偶联模式也不断涌现。药明康德旗下WuXi TIDES搭建了为寡核苷酸、多肽及复杂化学偶联药物开发提供一体化服务的CRDMO平台，覆盖从药物发现、CMC开发及商业化生产的全生命周期，尤其借助药明康德在化学业务方面的丰富经验，为赋能新一代偶联疗法奠定了坚实基础。本文将盘点2025年第三季度（Q3）偶联领域的最新进展，并介绍WuXi TIDES一体化CRDMO平台赋能多肽偶联药物开发的能力。抗体偶联药物：多款疗法获FDA突破性疗法认定，双特异性ADC崭露头角 2025年第三季度，多款创新ADC获得FDA授予的突破性疗法认定，这一认定旨在加快治疗严重疾病创新疗法的开发和审评，初步临床证据显示它们与已有疗法相比在具有临床意义的终点方面提供显著改善。获得突破性疗法认定的ADCs既包括已获批的重磅药物，也涵盖靶向新靶点的潜在“first-in-class”疗法，还包括一款双特异性ADC。这也是双特异性ADCs首次获得FDA授予的突破性疗法认定。 ▲2025年第三季度获得FDA突破性疗法认定的ADCs（数据来源：公开资料，截至9月22日）双特异性ADCs通过靶向两个不同靶点，或者同一靶点上的两个不同表位，与只与单个靶点接合的ADCs相比，可能增加与靶细胞接合的特异性，从而提高疗效并降低脱靶效应带来的潜在毒性。此外，靶向不同靶点蛋白可能让双特异性ADCs与更为广泛的细胞群体结合，从而克服肿瘤的异质性。这一领域正在得到业界越来越多的关注，在2025年Q3，多家公司在双特异性ADC领域取得进展。例如，百利天恒与百时美施贵宝（Bristol Myers Squibb）联合开发的靶向EGFR和HER3的潜在“first-in-class”双特异性ADC izalontamab brengitecan在治疗鼻咽癌的3期临床试验中，中期分析达到主要终点。在今年9月的世界肺癌大会（WCLC）上公布的数据显示，剂量为2.5 mg/kg的izalontamab brengitecan与EGFR抑制剂Tagrisso作为一线组合疗法，在治疗携带EGFR突变的非小细胞肺癌（NSCLC）患者的2期临床试验中，达到100%的客观缓解率（ORR）和95%的确认ORR，12个月无进展生存率为92.1%。康方生物的AK146D1是一款靶向Trop2和Nectin4的双特异性ADC，它在今年7月完成1a期临床试验的首例患者给药。Avenzo Therapeutics和映恩生物联合开发的EGFR/HER3靶向ADC AVZO-1418也完成1/2期临床试验的首位患者给药，用于治疗晚期实体瘤。天演药业与ConjugateBio公司在今年7月达成研发合作，ConjugateBio将利用天演药业开发的独有双特异性抗体进行双特异性ADC项目的开发。Radiance Biopharma则在9月与科弈药业达成研发和许可合作，共同开发潜在“first-in-class”靶向c-MET和EGFR的在研ADC RB-601（KY-0301）。在Q3 2025，多款靶向单一靶点的创新ADC也获得积极临床进展。例如，默沙东（MSD）与第一三共（Daiichi Sankyo）联合开发的B7-H3靶向ADC ifinatamab deruxtecan在治疗广泛期小细胞肺癌（ES-SCLC）的2期临床试验中表现出48%的确认ORR和87.6%的疾病控制率（DCR）。由PD-1抑制剂Keytruda与抗体偶联药物Padcev构成的组合疗法，作为围手术治疗方案，在治疗患有肌层浸润性膀胱癌（MIBC）且不适合使用以顺铂为基础化疗的患者的3期临床试验中，与单纯手术相比，在主要终点无事件生存期（EFS），以及关键次要终点总生存期（OS）和完全病理学缓解率（pCR）方面均取得了具有统计学意义和临床意义的改善。 BioNTech和映恩生物联合开发的HER2靶向ADC trastuzumab pamirtecan在治疗经治HER2阳性乳腺癌的关键性3期临床试验中，与活性对照ADC相比，在预定的期中分析中达到无进展生存期的主要终点。多家偶联药物新锐完成融资，放射性偶联药物备受关注 2025年第三季度，偶联药物领域的多家新锐陆续完成融资，为持续推动这一治疗模式的创新提供了强劲动力。其中，放射性偶联药物公司的表现尤其亮眼，在第三季度至少有7家专注于RDC药物开发的公司完成融资。例如ARTBIO在7月底宣布完成1.32亿美元B轮融资，获得资金将用于加速公司α粒子放射性配体疗法的开发进程。其针对转移性去势抵抗性前列腺癌的候选药物AB001已进入临床开发阶段。 ▲2025年第三季度偶联药物领域部分投融资活动（数据来源：公开资料，截至9月22日）虽然RDC在早期肿瘤成像和治疗方面均展现巨大潜力，但其药物结构复杂，通常由靶向配体、连接子、螯合剂和放射性同位素组成。其生产过程需要多学科的专业技术支持。药明康德综合性的放射性药物发现平台整合了多肽发现和放射性药物开发能力，提供包括多肽合成、螯合剂合成、放射性标记、成像、药理学研究和监管申报支持等完善的服务。一体化平台让多个团队并行攻坚、高度协作，帮助合作伙伴快速推动RDC项目，节省宝贵的开发时间。药明康德旗下WuXi TIDES CRDMO平台目前正在赋能各类偶联药物开发，覆盖多种疾病领域。回顾2025年第三季度，偶联药物领域在临床进展以及投融资方面都取得了可圈可点的进展。期待随着偶联技术的持续创新和优化，催生更多造福患者的突破。WuXi TIDES团队将继续利用其一体化的CRDMO平台赋能偶联药物的开发，帮助合作伙伴将科学创新早日转化成让全球患者获益的疗法。 CRDMO: Q3 2025 Review of Conjugated Therapeutics Conjugated drugs enable the precise delivery of therapeutic payloads to specific tissues or cells by linking target-binding ligands with functional payloads. In recent years, this field has advanced rapidly. According to a recent report, 284 antibody-drug conjugate (ADC) clinical trials were initiated globally in 2024—over 100 more than in 2023. Alongside ADCs, new conjugated modalities have also gained momentum, including radionuclide drug conjugates (RDCs), peptide-drug conjugates (PDCs), and oligonucleotide-drug conjugates. This growing momentum underscores the expanding potential of conjugated therapeutics in addressing a broad range of diseases. Backed by extensive experience in chemistry and integrated drug development expertise, WuXi TIDES is supporting next-generation conjugated therapies. As an integral part of WuXi AppTec, WuXi TIDES has built an integrated CRDMO platform focused on oligonucleotides, peptides and related synthetic conjugates. This platform simplifies TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. Antibody-Drug Conjugates: Multiple Therapies Receive FDA Breakthrough Therapy Designation In the third quarter of 2025, several innovative ADCs received Breakthrough Therapy designation (BTD). This designation is intended to expedite the development and review of treatments for serious diseases when preliminary clinical evidence indicates a substantial improvement on clinically meaningful endpoints over available therapies. Among the ADCs granted BTD are an approved blockbuster medicine, potential "first-in-class" therapies that target novel antigens, and one ADC designed to engage two antigens. Notably, this quarter marks the first time the FDA has awarded BTD to a bispecific ADC. Bispecific ADCs can engage two distinct targets—or two different epitopes on the same target—thereby increasing tumor-cell binding specificity relative to single-target ADCs. This enhanced selectivity may translate into improved efficacy and reduced off-target toxicity. In addition, by recognizing different antigens, bispecific ADCs may address a broader spectrum of tumor cells, helping to overcome intratumoral heterogeneity. Reflecting the growing interest in this modality, several bispecific ADC programs reported progress during Q3 2025. For example, izalontamab brengitecan, a potential "first-in-class" EGFR/HER3-targeting bispecific ADC, met the primary endpoint at interim analysis in a Phase 3 trial for nasopharyngeal carcinoma. Data presented at the World Conference on Lung Cancer (WCLC) in September also showed that izalontamab brengitecan at a dose of 2.5 mg/kg, combined with Tagrisso as a first-line therapy, achieved an objective response rate (ORR) of 100% and a confirmed ORR of 95% in a Phase 2 trial for patients with EGFR-mutant non-small cell lung cancer (NSCLC), with a 12-month progression-free survival (PFS) rate of 92.1%. In addition, a Trop2/Nectin-4 bispecific ADC and an EGFR/HER3-targeting ADC both completed the dosing of first patients in their first-in-human clinical trials. In July, Adagene entered into an R&D collaboration with ConjugateBio, under which ConjugateBio will leverage Adagene’s proprietary bispecific antibodies to develop bispecific ADC programs. In September, Radiance Biopharma reached a research and licensing collaboration with Novatim Immune Therapeutics to jointly develop RB-601 (KY-0301), a potential "first-in-class" investigational ADC targeting c-MET and EGFR. In Q3 2025, several innovative single-target ADCs also achieved encouraging clinical progress. For example, ifinatamab deruxtecan, a B7-H3-targeted ADC, demonstrated a confirmed ORR of 48% and a disease control rate (DCR) of 87.6% in a Phase 2 trial for extensive-stage small cell lung cancer (ES-SCLC). The combination therapy of the PD-1 inhibitor Keytruda with the ADC Padcev, as a perioperative treatment, showed statistically and clinically meaningful improvements compared with surgery alone in a Phase 3 trial in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The improvements were seen in the primary endpoint event-free survival (EFS), as well as the key secondary endpoints overall survival (OS) and pathologic complete response (pCR). Finally, trastuzumab pamirtecan, a HER2-targeted ADC, met the primary endpoint of progression-free survival in a pre-specified interim analysis of a pivotal Phase 3 trial in previously treated HER2-positive breast cancer, compared with an active control ADC. Sustained Innovation: Emerging Players Secure New Financing In Q3 2025, several emerging companies in the conjugate-therapy space completed new financing rounds, supporting continued innovation in this modality. Financing activities in RDC developers were especially prominent during Q3 2025, with at least seven companies completing rounds ranging from seed to Series C+, reflecting investors’ interest in different stages of RDC companies. Targeted alpha-particle therapies (TAT) continue to emerge as a focal point. TAT leverages the unique properties of alpha particles—such as high linear energy transfer (LET) and short tissue penetration—to deliver potent cytotoxic effects to cancer cells while minimizing damage to surrounding healthy tissue. Although RDCs have demonstrated potential in early tumor imaging and treatment, their complex drug structures—typically composed of a targeting ligand, linker, chelator, and radionuclide—require multidisciplinary technical expertise for development and manufacturing. WuXi AppTec offers a comprehensive radiopharmaceutical discovery platform that combines peptide discovery with radiopharmaceutical development, covering peptide synthesis, chelator synthesis, radiolabeling, imaging, pharmacology studies, and regulatory filing support. This integrated model enables parallel, highly collaborative efforts across multiple teams, helping partners accelerate RDC programs and save valuable development time. In summary, Q3 2025 has seen remarkable progress in the conjugated drug field across clinical milestones and financing activities. As innovation and optimization in conjugation technologies advance, the field is poised for even more breakthroughs that promise to benefit patients worldwide. WuXi TIDES remains committed to harnessing its fully integrated CRDMO platform to support the development of conjugated drugs—empowering partners to accelerate the translation of scientific innovation into transformative therapies. 参考资料： [1] Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC. Retrieved August 21, 2025, from https://www.prnewswire.com/news-releases/nature-medicine-publishes-results-of-phase-ii-study-of-sacituzumab-tirumotecan-plus-tagitanlimab-as-first-line-therapy-for-nsclc-302533389.html [2] Izalontamab Brengitecan (EGFRxHER3 ADC) Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer. Retrieved August 21, 2025, from https://www.prnewswire.com/news-releases/izalontamab-brengitecan-egfrxher3-adc-granted-breakthrough-therapy-designation-by-us-fda-for-patients-with-previously-treated-advanced-egfr-mutated-non-small-cell-lung-cancer-302531369.html [3] PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery. Retrieved August 21, 2025, from https://www.pfizer.com/news/press-release/press-release-detail/padcevtm-plus-keytrudatm-significantly-improves-survival [4] Genmab Receives FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S®) in Advanced Endometrial Cancer (EC). Retrieved August 26, 2025, from https://www.globenewswire.com/news-release/2025/08/26/3139199/0/en/Genmab-Receives-FDA-Breakthrough-Therapy-Designation-for-Rinatabart-Sesutecan-Rina-S-in-Advanced-Endometrial-Cancer-EC.html [5] Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma. Retrieved August 26, 2025, from https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/ [6] 自愿披露关于 iza-bren（EGFR×HER3 双抗ADC）用于治疗局部晚期或转移性鼻咽癌的III期临床试验的期中分析达到主要终点的公告. Retrieved August 26, 2025, from https://static.sse.com.cn/disclosure/listedinfo/announcement/c/new/2025-07-03/688506_20250703_96T7.pdf [7] Akeso's First Bispecific ADC (Trop2/Nectin4 ADC) Enters Clinical Trials, Strengthening Leadership in 'IO+ADC' 2.0 Strategy. Retrieved August 26, 2025, from https://www.prnewswire.com/news-releases/akesos-first-bispecific-adc-trop2nectin4-adc-enters-clinical-trials-strengthening-leadership-in-ioadc-2-0-strategy-302497499.html [8] Adagene and ConjugateBio Partner to Develop Novel Antibody Drug Conjugate. Retrieved August 26, 2025, from https://www.globenewswire.com/news-release/2025/07/08/3111594/0/en/Adagene-and-ConjugateBio-Partner-to-Develop-Novel-Antibody-Drug-Conjugate.html [9] Avenzo Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Study of AVZO-1418, a Potential Best-in-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate. Retrieved August 26, 2025, from https://avenzotx.com/press-releases/avenzo-therapeutics-announces-first-patient-dosed-in-phase-1-2-clinical-study-of-avzo-1418-a-potential-best-in-class-egfr-her3-bispecific-antibody-drug-conjugate/ [10] ENHERTU® Plus Pertuzumab Granted Breakthrough Therapy Designation in the U.S. as First-Line Therapy for Patients with HER2 Positive Metastatic Breast Cancer. Retrieved August 26, 2025, from https://daiichisankyo.us/press-releases/-/article/enhertu-plus-pertuzumab-granted-breakthrough-therapy-designation-in-the-us-as-first-line-therapy-for-patients-with-her2-positive-metastatic-breast-cancer [11] ARTBIO Announces $132 Million Series B Financing to Advance Pipeline of Alpha Radioligand Therapies and Expand Manufacturing and Supply Chain Infrastructure. Retrieved August 26, 2025, from https://www.prnewswire.com/news-releases/artbio-announces-132-million-series-b-financing-to-advance-pipeline-of-alpha-radioligand-therapies-and-expand-manufacturing-and-supply-chain-infrastructure-302515362.html [12] Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01). Retrieved August 26, 2025, from https://www.globenewswire.com/news-release/2025/07/28/3122434/0/en/Radiopharm-Theranostics-Receives-IND-approval-from-US-FDA-to-Initiate-Phase-I-Therapeutic-Clinical-Study-to-target-B7H3-with-Betabart-RV-01.html [13] NUCLIDIUM Closes CHF 79 Million (EUR 84 Million) Series B Financing to Advance Clinical Development of its Copper-based Radiopharmaceutical Platform. Retrieved August 26, 2025, from https://nuclidium.com/nuclidium-closes-chf-79-million-eur-84-million-series-b-financing-to-advance-clinical-development-of-its-copper-based-radiopharmaceutical-platform/ [14] Actithera Raises $75.5M in Oversubscribed Series A Financing to Redefine Precision Radioligand Therapy. Retrieved August 26, 2025, from https://www.prnewswire.com/news-releases/actithera-raises-75-5m-in-oversubscribed-series-a-financing-to-redefine-precision-radioligand-therapy-302500396.html [15] Primo Biotechnology Secures A Funding and Targets 2026 IPO to Strengthen Global Radiopharmaceutical Strategy. Retrieved August 26, 2025, from https://www.globenewswire.com/news-release/2025/07/02/3109203/0/en/Primo-Biotechnology-Secures-A-Funding-and-Targets-2026-IPO-to-Strengthen-Global-Radiopharmaceutical-Strategy.html [16] Ifinatamab Deruxtecan Demonstrated Clinically Meaningful Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial. Retrieved September 8, 2025, from https://www.merck.com/news/ifinatamab-deruxtecan-demonstrated-clinically-meaningful-response-rates-in-patients-with-extensive-stage-small-cell-lung-cancer-in-ideate-lung01-phase-2-trial/ [17] IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer. Retrieved September 8, 2025, from https://www.prnewswire.com/news-releases/ideaya-biosciences-and-hengrui-pharma-present-positive-phase-1-data-for-ide849-shr-4849-a-potential-first-in-class-dll3-top1-adc-in-small-cell-lung-cancer-at-the-iaslc-2025-world-conference-on-lung-cancer-302548425.html [18] BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer. Retrieved September 8, 2025, from https://investors.biontech.de/news-releases/news-release-details/biontech-and-dualitybio-announce-phase-3-trial-adc-candidate [19] Radiance Biopharma Signs Exclusive License For ‘First In Class’ c-Met/EGFR Targeted Nano Antibody ADC. Retrieved September 8, 2025, from https://www.globenewswire.com/news-release/2025/09/03/3144055/0/en/Radiance-Biopharma-Signs-Exclusive-License-For-First-In-Class-c-Met-EGFR-Targeted-Nano-Antibody-ADC.html [20] New Antibody-Drug Conjugate Shows Promising Efficacy in EGFR-Mutated NSCLC Patients. Retrieved September 8, 2025, from https://www.iaslc.org/iaslc-news/press-release/new-antibody-drug-conjugate-shows-promising-efficacy-egfr-mutated-nsclc [21] Iza-bren and osimertinib combination shows 100% response rate in EGFR-mutated lung cancer. Retrieved September 8, 2025, from https://newsatw.com/iza-bren-and-osimertinib-combination-shows-100-response-rate-in-egfr-mutated-lung-cancer/ 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

突破性疗法抗体药物偶联物临床结果快速通道临床3期

2025-08-22

·EINPresswire

New hope for bladder cancer patients as breakthrough treatment doubles survival

More than a thousand patients living with bladder cancer every year can now receive a breakthrough treatment that can double survival rates from the disease. The treatment which has been approved for use on the NHS from today has been hailed as ‘one of the most hopeful advances in decades for people with bladder cancer.’ Around 1,250 patients with bladder cancer in England a year could be offered the therapy, which significantly boosts survival and remission rates. In clinical trials of the drug, people with bladder cancer that had spread (metastasised) lived up to twice as long when given the combination antibody treatment compared to those given normal chemotherapy. The combination treatment works by using a powerful two-pronged attack, with enfortumab vedotin directly targeting the cancer cells and killing them, while pembrolizumab, an immunotherapy drug, helps the immune system recognise and fight the remaining cancer cells. It is given via an IV infusion to people whose bladder cancer has spread to other parts of the body or cannot be surgically removed. Bladder cancer is difficult to treat with standard chemotherapy, with life expectancy for people with metastatic bladder cancer at just over a year. The new approach increased survival from around 1.5 years with chemotherapy to more than 2.5 years. The length of time the treatment kept the cancer at bay also more than doubled – from just over 6 months to 1.5 years. Additionally, nearly 30% of patients had no detectable traces of cancer in their body following treatment with enfortumab vedotin and pembrolizumab, compared to 12.5% with chemotherapy. Patients also experienced fewer harmful side effects with the combination treatment, thanks to its selective targeting of the cancer. Professor Peter Johnson, NHS England’s National Clinical Director for Cancer, said : “This is one of the most hopeful advances in decades for people with bladder cancer who will now be offered a treatment that can almost double their chances of survival, helping thousands to live longer and giving them more precious moments with their loved ones. “Bladder cancer is often difficult to treat once it has spread, but this new therapy is the first one in years to really help stop the disease in its tracks, and our rollout to NHS patients will make a huge difference to the lives of those affected and their families”. Martyn Hewett, 75 years old, from Stratford, East London, received the combination treatment on a trial at Barts Health NHS Trust after surgery to remove his tumours failed. He said : “I feel very, very lucky, because if I hadn’t been on this trial, I imagine I would be dead by now. “Immediately after the operation that failed, I asked the doctor what the prognosis was, and he said, most people in your position live for a year, and now, three and a half years later here I am. I am going to have an extra few years to see my grandson grow up – and maybe even be around to see him get married”. More than 10,000 people are diagnosed with bladder cancer each year in the UK. Bladder cancer can be difficult to treat as it can be asymptomatic, especially in its early stages – and once it spreads beyond the bladder, it can be aggressive and more resistant to chemotherapy. The treatment has been made available thanks to commercial deals struck by NHS England with manufacturers Astellas Pharma and MSD UK, which enabled the National Institute for Health and Care Excellence (NICE) to deem it cost-effective. The rollout is the latest in a series of NHS innovations in cancer care, following the adoption of belantamab mafodotin for blood cancer, the fast-tracking of pembrolizumab for advanced womb cancer, and the launch of mRNA vaccine trials for head and neck cancers. It shows the NHS continuing to raise the bar in cancer care by embracing the latest innovation and offering the hope of longer and healthier lives. Minister for Health, Stephen Kinnock said : “For people with cancer, every moment matters. “This breakthrough treatment will give people precious extra time with their families. This is exactly what modern healthcare looks like – saving lives by providing access to the best support available. “Through our Plan for Change, we’re turning the tide after years of cancer services being run into the ground and delivering the world class treatments people to deserve, that will create an NHS fit for the future”. Jeannie Rigby, CEO of Action Bladder Cancer UK, said : “ABC UK, bladder cancer patients and their families welcome this effective, and much-needed, alternative treatment. This new treatment can increase how long people have before their cancer gets worse and how long they live compared with current treatments available – while also providing a better quality of life with less adverse side effects”. Dr Tim Patel, Medical Director for the UK at Astellas Pharma, said : “For many decades, most patients with unresectable or metastatic bladder cancer have initially been given platinum chemotherapy, which works by damaging the DNA of all fast-multiplying cells (including cancer cells) throughout the body. Enfortumab vedotin offers a different approach by including an antibody designed to directly attach to bladder cancer cells and deliver a chemotherapy payload into those cancer cells. “In combination with pembrolizumab, enfortumab vedotin has been shown to double survival versus platinum chemotherapy with a manageable side effect profile. We are proud to have worked with NICE and the NHS to make the combination of enfortumab vedotin and pembrolizumab available to eligible patients across England and Wales”. Benson Fayehun, Head of Oncology at MSD in the UK, said : “We welcome NICE’s decision to recommend this treatment for advanced bladder cancer – a condition where patients have long faced limited options and poor outcomes. The findings from the EV-302/KN-A39 study, which suggest the potential to nearly double both progression-free and overall survival, mark a significant step forward. This recommendation offers patients and clinicians a much-needed alternative care option”. Professor Thomas Powles, Chair of the Barts Cancer Centre at St Bartholomew’s Hospital, who led the research, said : “This treatment is a major step forward for people with advanced bladder cancer, with outcomes twice as effective as previous chemotherapy. At Barts Health, we’ve seen patients on this trial gain lasting benefit, bringing real hope to thousands facing this aggressive disease”. Background Trial results included in the release available here: Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer | New England Journal of Medicine The global phase 3 trial EV-302 was an open-label, randomised trial to compare the efficacy and safety of enfortumab vedotin with pembrolizumab (EV/P) against platinum-based chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma. Progression-free survival and overall survival were assessed. 886 patients took part in the trial. Enfortumab vedotin is an antibody drug conjugate and pembrolizumab is an immunotherapy drug. The main symptoms of bladder cancer include blood in the urine, changes in urination habits like increased frequency, and pain or burning during urination. Less common symptoms include lower back pain, bone pain, loss of appetite and unexplained weight loss. Key results Overall survival was 31.5 months with EV/P and 16.1 months with chemotherapy. The risk of disease progression or death was reduced by 55% with EV/P over chemotherapy. Progression free survival was 12.5 months with EV/P and 6.3 months with chemotherapy. Estimated percentage of patients alive at 12 months was 78.2% for EV/P and 61.4% for chemotherapy. Percentage of patients with a complete response was achieved in 29.1% with EV/P compared with 12.5% on chemotherapy. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床3期免疫疗法疫苗上市批准

100 项与玛贝妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11595	玛贝妥单抗	L01XC	DB15719

研发状态

批准上市

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适应症	国家/地区	公司	日期
复发性浆细胞骨髓瘤	日本	GlaxoSmithKline KK	2025-05-19
多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05
难治性多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05
复发性多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05

未上市

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适应症	最高研发状态	国家/地区	公司	日期
残留肿瘤	临床2期	美国	GSK Plc	2024-08-19
骨髓肿瘤	临床2期	美国	GSK Plc	2022-07-21
浆细胞白血病	临床2期	美国	GSK Plc	2022-07-21
角膜疾病	临床2期	希腊	GSK Plc	2022-04-13
BCMA阳性多发性骨髓瘤	临床2期	美国	GSK Plc	2022-02-21
ALK阳性大B细胞淋巴瘤	临床2期	美国	GSK Plc	2021-07-01
浆母细胞淋巴瘤	临床2期	美国	GSK Plc	2021-07-01
免疫球蛋白轻链淀粉样变性	临床2期	法国	GSK Plc	2021-02-26
免疫球蛋白轻链淀粉样变性	临床2期	德国	GSK Plc	2021-02-26
免疫球蛋白轻链淀粉样变性	临床2期	希腊	GSK Plc	2021-02-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05986682 (Pubmed \| Clin Lymphoma Myeloma Leuk)	N/A	复发性多发性骨髓瘤	30	Belantamab Mafodotin	獵鏇鹹願壓夢餘襯夢願(積淵糧製夢積鏇鑰襯鹹) = Keratopathy (any grade) occurred in 28 (93%); 2% of events were grade ≥3 廠鹽築繭網鏇廠選餘衊 (襯醖範鹽淵網蓋網襯鹽 ) 更多	积极	2025-08-01
["DREAMM-7"] (Pubmed \| Lancet Oncol)	临床3期	难治性多发性骨髓瘤	494	Belantamab mafodotin+bortezomib+dexamethasone (BVd)	淵鹹鹽糧觸夢壓鑰願鬱(顧壓鏇獵憲窪蓋夢鑰構) = 壓觸憲糧鹹衊鑰鹽膚襯襯顧襯膚積範糧醖遞簾 (餘獵鑰獵鬱餘選壓顧鹽, NR ~ NR) 更多	积极	2025-08-01
				Daratumumab+bortezomib+dexamethasone (DVd)	淵鹹鹽糧觸夢壓鑰願鬱(顧壓鏇獵憲窪蓋夢鑰構) = 鏇遞壓觸鏇齋窪鑰淵糧襯顧襯膚積範糧醖遞簾 (餘獵鑰獵鬱餘選壓顧鹽, 41.0 ~ NR)
NCT06956170 (DREAMM 8, CTgov)	临床3期	复发性多发性骨髓瘤	21	Mafodotin+Pomalidomide+Dexamethasone+Belantamab (Belantamab Mafodotin+Pomalidomide+Dexamethasone)	膚餘願憲襯壓壓繭觸鏇(壓繭餘鑰構範範夢廠築) = 壓膚淵醖淵簾築鹹襯醖憲鹹窪艱醖蓋獵蓋衊範 (醖網構蓋衊夢齋範艱範, 艱壓鑰願淵繭積餘鑰顧 ~ 構觸淵繭鏇簾艱糧膚鬱) 更多	-	2025-06-11
				Pomalidomide+Bortezomib+Dexamethasone (Bortezomib + Pomalidomide + Dexamethasone)	膚餘願憲襯壓壓繭觸鏇(壓繭餘鑰構範範夢廠築) = 構夢窪製遞積蓋築網餘憲鹹窪艱醖蓋獵蓋衊範 (醖網構蓋衊夢齋範艱範, 鬱窪膚齋膚範顧餘積範 ~ 蓋觸襯鹽顧積餘繭糧憲) 更多
NCT04549363 (Pubmed \| JAMA Ophthalmol)	临床3期	多发性骨髓瘤	9	Belantamab Mafodotin	觸鏇鹹衊鹽壓襯醖糧鹹(鹽齋繭夢願齋膚糧鹹範) = In this case series study, intracytoplasmic inclusions were observed by histopathology in the corneal epithelium of patients exposed to belantamab mafodotin, and the pattern of corneal changes suggests limbal vessels may be a primary pathway enabling ADC to reach the cornea 鹹膚淵鹹壓遞製餘構淵 (構襯範鏇壓積鏇鑰襯壓 ) 更多	-	2025-06-01
NCT04808037 (BELARD, ASCO2025)	临床1/2期	多发性骨髓瘤	66	Belantamab mafodotin 1.9 mg/kg	獵糧顧網願艱夢觸艱襯(鬱鬱觸選蓋網憲鏇艱繭) = ≥10% 繭衊選顧獵衊獵淵廠襯 (夢鑰願齋齋憲襯鹹簾顧 ) 更多	积极	2025-05-30
				Lenalidomide
DREAMM-7, DREAMM-8 (ASCO2025)	临床3期	复发性多发性骨髓瘤 anti-CD38	-	Belantamab mafodotin + pomalidomide + dexamethasone (BPd)	獵獵餘願衊壓廠鬱築繭(窪顧範積鏇鏇醖構糧蓋) = 襯艱齋願餘範鹽簾壓積範齋齋構鏇鹽鹹醖簾廠 (遞鬱構壓範製鏇膚構齋 ) 更多	积极	2025-05-30
				Daratumumab + bortezomib + dexamethasone (DVd)	獵獵餘願衊壓廠鬱築繭(窪顧範積鏇鏇醖構糧蓋) = 衊艱鏇膚鏇醖觸鹽艱簾範齋齋構鏇鹽鹹醖簾廠 (遞鬱構壓範製鏇膚構齋, 6.4 ~ 19.1) 更多
ASCO2025	N/A	复发性多发性骨髓瘤 BCMA	-	Belantamab mafodotin	獵襯鑰鬱選鹹廠窪築獵(簾獵衊鬱範積鏇壓繭繭) = 47.3% (95% CI: 40.2-54.4) 襯衊糧齋餘糧廠膚網襯 (鬱衊夢願憲膚築鏇築憲 ) 更多	积极	2025-05-30
NCT04484623 (DREAMM-8, ASCO2025)	临床3期	多发性骨髓瘤 t(4;14) \| t(14;16) \| amp1q ... 更多	302	Belantamab mafodotin plus pomalidomide and dexamethasone (BPd)	構範鏇糧醖鑰製網鑰遞(願醖窪蓋繭繭範壓繭糧) = 觸遞觸積襯鏇製願觸鏇繭衊鹽襯積淵製製蓋鏇 (範蓋窪齋鏇淵淵醖廠製 ) 更多	积极	2025-05-30
				Pomalidomide plus bortezomib and dexamethasone (PVd)	構範鏇糧醖鑰製網鑰遞(願醖窪蓋繭繭範壓繭糧) = 餘憲蓋顧憲鹽廠鹽艱遞繭衊鹽襯積淵製製蓋鏇 (範蓋窪齋鏇淵淵醖廠製 ) 更多
NCT04246047 (DREAMM-7, ASCO2025)	临床3期	多发性骨髓瘤 t(4;14) \| t(14;16) \| 17p13del ... 更多	494	Belantamab mafodotin plus bortezomib and dexamethasone (BVd)	艱鹽願衊選餘獵糧簾膚(獵淵蓋積鹽獵壓範餘願) = 顧築願餘糧蓋願鏇製選構廠觸憲鬱衊餘夢製繭 (鹹齋觸網製觸蓋窪積構 ) 更多	积极	2025-05-30
				Daratumumab plus bortezomib and dexamethasone (DVd)	艱鹽願衊選餘獵糧簾膚(獵淵蓋積鹽獵壓範餘願) = 鑰糧簾窪鑰築鏇淵蓋窪構廠觸憲鬱衊餘夢製繭 (鹹齋觸網製觸蓋窪積構 ) 更多
DREAMM-3, DREAMM-7, DREAMM-8 (ASCO2025)	临床3期	复发性多发性骨髓瘤	-	Belantamab mafodotin	願憲齋襯鏇艱廠繭淵鬱(構積糧構積醖鏇鏇壓構) = 鏇膚鹽鑰壓鬱鬱顧壓獵齋顧醖獵願廠齋範鏇範 (築壓鏇願築製範餘醖繭, 4.97 ~ 8.60) 更多	不佳	2025-05-30
				belantamab mafodotin (Control Group)	願憲齋襯鏇艱廠繭淵鬱(構積糧構積醖鏇鏇壓構) = 襯選壓齋簾淵艱淵築襯齋顧醖獵願廠齋範鏇範 (築壓鏇願築製範餘醖繭 ) 更多